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Behavioural Intervention

Antibiotic Stewardship at Discharge for Pneumonia (ROAD Home Trial)

N/A

Waitlist Available

Led By Valerie M Vaughn, MD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have normal urinary anatomy

Admitted to a general care medicine service

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months; from discharge prescription

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if an antibiotic stewardship approach tailored to a hospital's needs can reduce antibiotic overuse at discharge in hospitalized patients with CAP or UTI.

Who is the study for?

This trial is for adult patients hospitalized with pneumonia or a urinary tract infection (UTI) who have normal urinary anatomy, are generally healthy immune-wise, and are admitted to general care. They must not be on antibiotics for other infections and should have received certain antibiotics during their hospital stay.

What is being tested?

The ROAD Home Intervention aims to reduce antibiotic overuse when patients with community-acquired pneumonia or UTI leave the hospital. It compares customized stewardship plans in some hospitals against standard practices in others, measuring antibiotic use after discharge.

What are the potential side effects?

Since this study focuses on improving antibiotic use rather than testing new drugs, it does not directly involve side effects of medications. However, better stewardship may lead to fewer drug-related complications like resistance or adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My urinary system is normal.

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I am currently admitted to a general care unit at a hospital.

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I am not currently being treated for an infection.

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I was diagnosed with pneumonia at my last hospital discharge.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months; from discharge prescription

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months; from discharge prescription

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months; from discharge prescription for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Days of antibiotic overuse at hospital discharge

Secondary study objectives

Number of cases with antibiotic-associated adverse events

Other study objectives

Number of cases with 30-day C Difficile infection

Number of cases with 30-day mortality

Number of cases with 30-day readmission

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ROAD Home InterventionExperimental Treatment1 Intervention

Hospitals randomized to receive the ROAD Home Intervention will receive an implementation intervention that includes external facilitation to support them in selecting and implementing evidence-based antibiotic stewardship strategies based on local context and the ROAD Home framework (https://academic.oup.com/cid/article/74/9/1696/6374407).

Group II: Stewardship as UsualActive Control1 Intervention

Hospitals randomized to the control group will continue usual antibiotic stewardship activities. Although control hospitals are part of the HMS collaborative, during the intervention period they will not receive any of the ROAD Home Intervention components including analysis of their baseline data or needs assessment, customized suite of stewardship strategies, supported decision-making in selecting ROAD Home strategies to implement, an implementation blueprint, adaptable stewardship tools, or external facilitation from study investigators.

0 / 4Eligibility criteria met